IOWA CITY, Iowa, Nov. 28 VIDA Diagnostics Inc. announcedtoday that its primary product, Pulmonary Workstation 2.0 (PW2) has obtainedFDA 510(k) clearance for sale.
PW2 is the first commercial release of lung image analysis software fromVIDA and comprises a comprehensive approach to quantitative, repeatable lungmeasurements including the industry's first so-approved automatic lobe densityand airway system measurement functions.
"We are privileged to be given the opportunity to make our leading PW2application available to assist in the evaluation of millions of chronicobstructive pulmonary disease (COPD) and emphysema patients throughout theU.S.," said John Garber, VIDA CEO. "Since these diseases often affect specificregions of the lung, the ability to individually and objectively measure eachof the five lobes and 25 major airways should fast become an invaluablecomplement to existing systemic measures like pulmonary function tests."
VIDA's PW2 takes the complex information from a CT (computed tomography)scan of the lung and converts it into useful 3D images and measurements thatare easily viewed by the practicing pulmonologist at the point of patientservice, or by the radiologist in the radiology department. PW2 featuresinclude a number of lung or lobe volume and density measurements, an extensivenamed airway map and a full suite of measurement tools for each airway. Forthe first time, airway, lung, and lobe measurement tools are combined withadvanced airway visualization to aid in patient assessment and procedureplanning.
"With installations at 27 top research sites processing over 10,000 CTscans in the last three years, PW2 has proven to be a very reliable softwarepackage," said Juerg Tschirren, VIDA Vice President of Engineering. "Afterextensive validation and testing, we are pleased to release our software,Pulmonary Workstation 2.0, for clinical use."
SOURCE VIDA Diagnostics Inc.